Certified Professional in Medical Device Packaging Compliance
-- ViewingNowCertified Professional in Medical Device Packaging Compliance (CPMDP) is designed for professionals needing expertise in medical device packaging regulations. This certification covers ISO 11607, EU MDR, and FDA regulations.
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2个月完成
每周2-3小时
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课程详情
- ISO 11607-1: Packaging for terminally sterilized medical devices
- ISO 11607-2: Packaging materials for terminally sterilized medical devices
- ASTM F1980: Standard Guide for Packaging, Labeling, and Sterilization of Medical Devices
- USP : Sterility tests
- ISO 13485: Medical devices – Quality management systems – Requirements for regulatory purposes
- 21 CFR Part 820: Quality System Regulation
- ISPE Good Practices Guide: Sterile Product Packaging
- EU Medical Device Regulation (MDR) 2017/745
- FDA Guidance Documents on Medical Device Packaging
职业道路
Job Title (Certified Professional in Medical Device Packaging Compliance) Description Packaging Engineer (Medical Devices) Develops and validates packaging solutions for medical devices, ensuring compliance with regulations like ISO 11607.
Focuses on material selection, design, and testing.
Regulatory Affairs Specialist (Medical Device Packaging) Manages regulatory submissions and ensures compliance with all relevant guidelines concerning medical device packaging.
A key role in maintaining compliance.
Quality Assurance Auditor (Medical Device Packaging) Audits packaging processes and documentation to ensure adherence to quality standards and regulatory requirements.
Crucial for maintaining product quality and safety.
Packaging Validation Specialist (Medical Devices) Specializes in validating packaging processes and ensuring sterility, integrity, and protection of medical devices throughout their shelf life.
入学要求
- 对主题的基本理解
- 英语语言能力
- 计算机和互联网访问
- 基本计算机技能
- 完成课程的奉献精神
无需事先的正式资格。课程设计注重可访问性。
课程状态
本课程为职业发展提供实用的知识和技能。它是：
- 未经认可机构认证
- 未经授权机构监管
- 对正式资格的补充
成功完成课程后，您将获得结业证书。
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